BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age17-75
SponsorBioSyngen Pte Ltd
About this trial
This study is an exploratory research on single arm, open, and improved "3+3" dose escalation. BGT007 will explore two dose groups, namely (Group A: 3.0X10 \^ 8 3 cases, Group B: 6.0X10 \^ 8 3 cases), and receive the same dose infusion after observing lower adverse reactions and initial benefits (SD or PR), with an interval of one month. Each subject can receive a maximum of 3 infusions in total.
Eligibility criteria
Qualifiers
1: Voluntarily sign a written informed consent form;
2: Age ≥ 18 years old and ≤ 75 years old, both male and female are acceptable;
3: Expected survival period ≥ 3 months;
4: The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
Disqualifiers
1: Active central nervous system metastases (excluding those that have been treated and stabilized);
2: HIV positive, HBsAg positive with HBV DNA copy number positive (greater than the detection limit), HCV antibody positive and HCV RNA positive, syphilis non-specific antibody (RPR or TRUST) positive;
3: Individuals with mental or psychological disorders who are unable to cooperate with treatment and efficacy evaluation;
4: Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
Trial design
Treatments tested in this trial
- Group A
- Group B
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
BioSyngen Pte Ltd
Lead sponsor
South China Hospital of Shenzhen University
Collaborator
Source ClinicalTrials.gov